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S6l,^cG*t#by MV Ҭ ɺTs'Ïŕy^߱⮮@gՈ=V~Mq_2Tl?-?#F:Ɨ˄P&{M7q!7m_Y;5ej|;Y/yA<*Mɕ` AF$ᔯ̣\H3gs}3m78T7wLr43ۺQi 4 endstream endobj 371 0 obj << /S /URI /URI (mailto:john.murray@fda.hhs.gov) >> endobj 372 0 obj << /S /URI /URI (mailto:david.buckles@fda.hhs.gov) >> endobj 375 0 obj << /Type /Metadata /Subtype /XML /Length 1556 >> stream 2005-01-18T14:13:55-05:00 2005-01-18T14:16:14-05:00 Acrobat Distiller 5.0.5 (Windows) Acrobat PDFMaker 5.0 for Word Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Issued: 01-14-2004 Author: John F. Murray Jr., David S. Buckles Posted: 01-18-2005, cybersecurity, software, networking 2005-01-18T19:13:55Z 2005-01-18T19:13:55Z 2005-01-18T14:16:14-05:00 Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff endstream endobj xref 0 376 0000000343 65535 f 0000000016 00000 n 0000000364 00000 n 0000000392 00000 n 0000002262 00000 n 0000002283 00000 n 0000002628 00000 n 0000006400 00000 n 0000006421 00000 n 0000006770 00000 n 0000006819 00000 n 0000009564 00000 n 0000009586 00000 n 0000009954 00000 n 0000010109 00000 n 0000014893 00000 n 0000014915 00000 n 0000015316 00000 n 0000015472 00000 n 0000015628 00000 n 0000020869 00000 n 0000020891 00000 n 0000021239 00000 n 0000024274 00000 n 0000024296 00000 n 0000024537 00000 n 0000024722 00000 n 0000024875 00000 n 0000025055 00000 n 0000025277 00000 n 0000034243 00000 n 0000034455 00000 n 0000042112 00000 n 0000042317 00000 n 0000048978 00000 n 0000049183 00000 n 0000055941 00000 n 0000056157 00000 n 0000056449 00000 n 0000056601 00000 n 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Gzft u6F V"ڷbh[o a-.OEzhяb(;J(,C+OlQppdJncn> endobj 395 0 obj<> endobj 396 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=n髢*8@زċ9N ~@ CKׂ w4.%6&Q=_n437j͹˩x%& s AP Qw䟧ܡKn$ Gόzft t6F{ "wbh[o a).Ezhяb(:J(,C+OlQppbFҬncn> endobj 398 0 obj<> endobj 399 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=EQQŒrXeEŜX'zK? ![ |r?[/7oܥԁK ) NBWx; bSrPG%7^gӍg&=3i M{:-[yrEei7 |igdSu=rJG1`p|MAC J%ʡ'(kHv8q!i617f|J:+qG&6 kmQ[akp\>GIگxc\832)AP7*%pGC)qkluJ.wE.EI]a2-vpm32-?[iLNB 4g2d\GWQ:0pYl*/v_ؙ endstream endobj 400 0 obj<> endobj 401 0 obj<> endobj 402 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=v5QQŒrlXeEV'v+? !K M|r?;/7neԁK NBWx; bSrPG%7^gӍg=3 Mw:[yrEe{i7 |iGdSt=rJG1`pz AC J%ʡ'(kHv8qi17f|H+qG& [mQKaip\>GIoxc\832)AP7)%pEC)q kluJvE.=I]a2,vpm31>KiLNB 4g2d\G7Q:0pWl*/ k endstream endobj 403 0 obj<> endobj 404 0 obj<> endobj 405 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=Fm(( NaFT9~2^N9ҝ`meKwÆutpq 嗛eZs%FH'T@CCE1)cc9wƒ/Io33sݴsæ9Mц<_UHX4>wX˴uѩ9%|m08f ݊[5\$;׸4{ۘ3>#O}˸#ۄKH(PZ38.$Uo헉V1.vM tYֵz6 :%DWgMϮ0PD;FE_V4 c'!]Ō`32fzË(B*6Lvt`/ endstream endobj 406 0 obj<> endobj 407 0 obj<> endobj 408 0 obj<>stream HVrH +pLFɞJbK*'sJr`HL$bnR iҖ4EYgi⢮hu}<&n<"e 7HaG=rbU@(1/e+leAM5 f Hg_-FP6>,)g/es(dMU0T?oVhoYh(9hÈһ&$f֤řI%I5@86$q%ms tWoBnv &,c[6 v>W|> endobj 410 0 obj<> endobj 411 0 obj<>stream HVrH}WcR͝T*\\$OI Doπ.`==(l5z5(ޤ |-|)>G,avyYB-RX_\a2/)P*' 2KEt^l2ۥuPf;|a]M., )0W a#QTjw29ar&B*\8]7 n7,XB4A2bGzϒ(SX%|ȓ}Uxcm$0Tչg6m)̫О HtF=Ïx_f1ԑjUjdhΈD7i]̋a]HKX趨O+*L\Eכ%\a3x蠸"uy]lrxKf_\P)re gyLj!"鑏鄥;:$H:(EgfDdȺ;a%qivʈRL<Et%$pmʦRQ,?,xRFƞzvĹ'?o((aF49v~2ZN5܍`MeKwF߇|r?o7kܥӁK K'T@CCE11c[9wƒ/Io|3S4sæ5v<_5HoX4wX˴uѩ9%|m08& ۊ[5\$;ָ4[ۘ3>!O]˸#KH(PZ18._$EoWV1.vM t{Yֵz6 w:%DgMϮ0PD;FCn_ 4 c'!]Ō`32fzk(A(6Lvt`n@ endstream endobj 412 0 obj<> endobj 413 0 obj<> endobj 414 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=롰8:ج%ċb9N V~@ CK 4.|6&!=v_n(37j͹˦x# ՗ NBWx; bSǮrPG%7^fӍg<3Mg:k݂[yKrEe~i7 |icSp=rJG1`pr @C J%ʡ'(kHv8qi17f|@*qG&[mQ aap\>GI{oxc\832)AP7%%p=B)qkltJuE.I]a2(vpm3-= iLNB 4g2d\GP:0pOl*x/+ endstream endobj 415 0 obj<> endobj 416 0 obj<> endobj 417 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=}PQŒ(rUeEL'b ? ![v |r?/7i%ӁK ҍK'T@CCE1)cS9wƒ/Iox333ݴsæ1uf<_HmX4>wX˴ӱuѩ9%|m08柡 ي[5\$;ո4;ۘ3>O=˸#[KH(PZ}/8.$5oV1.vM t;Yֵz6 7:%D׺gMϮ0PD;FA_֞4c'!]Ō`32fzK(@&6Lvt`(֍ endstream endobj 418 0 obj<> endobj 419 0 obj<> endobj 420 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=|PQ ŒrlUeEJ'^k ? !;r ͽ|r?{/7hҁK MK'T@CCE1)cO9wƒ/Iov33#tsæ/5^<_H]X4>wX˴ñu)9%|m08Ɵ ؊[5\$;Ը4+ۘ3>O-˸#;}KH(PZu.8.$-oV1.vM tYֵz6 :%DgMϮ0PD\;F@Ƕ4c'!]Ō`32fz;(@%6Lvt`( endstream endobj 421 0 obj<> endobj 422 0 obj<> endobj 423 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=b(( aF8v~2RN-m` eKwutpq䗛MdZsR%醈B%U!!¢;Qcɍ7t όnaӖzhV/z\wQY_Cm Dy;eZغT[m>Q 6[gPR rkE-.j\Dm̍eܑIʁ Bລx[s(-qQᒷkD+;ŌL uԍF M}PJܿ,Ze=kK]ѳ pAҦgw( n#ܟvw̯cKyñ'fB0M j3Wvl=\& x;[: 0ռ endstream endobj 424 0 obj<> endobj 425 0 obj<> endobj 426 0 obj<>stream HVrH +pLF=JM,e$qNI IIL$bnR iҖ4ū6Q\ËWuŻ4/o&ŧhQ9,R%V V@B˗W%5PANt.}Qf.lx/lU8[!fF!a0J`cÑX a ?fODw:gO.Zw[e! 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NBW bCʧrQG%7^fӭG;3mmS[yqDe[~wiw kXsѫ9%| m0:.f Պ[^%Ӹڔ3=˸'ۃeKH(PZ]+8.$o뗈N).vL }Yַ6 9%DWb`zn0PD{F=n_V<c/!]Ō` 2e^Fz (>"Ln` endstream endobj 430 0 obj<> endobj 431 0 obj<> endobj 432 0 obj<>stream HVMsHW1Z曙TjmI*o{Jr $ @v~{[:0%5_EYg(͛E]G&M,,,|Ka)ZgyTgE7|n‚Pwb|I!/Tq>a-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%=WBaG%ph3"ƱMer 83&h\54mM{#8fnc՚sG.H7A.AP Qw䟧ܡKn$ Gόwft tG "wbh[o a-Ezhяb(:}J(,CS+OlQppJҬkcnh6JbmReY*(\]#芞]ۑ6=@epEf~OxWXw=1ibdUgt`0T_ry endstream endobj 433 0 obj<> endobj 434 0 obj<> endobj 435 0 obj<>stream HVMsHW1Z曙TjmI*'و=%9$ @v~{[:0%5_EYg(͛E]G&M,,,|Ka9ZgyTgE7|n‚Pwb|I!/Tq>a_-ݧb[.,2 jrNfaHAPc|=|papd$VC 3&WQ"_/к߰` Pb8hˈ5>K).]M:1T"X34ct!c.ix`Iۢ~>\'2q]o `;s-ࡃ v{M}YFpS@M jV\H =ꌣ :_$"ME9=+6eO='MHSFl:ge,,%}sFP6RLbf22OSC%= ӣ83إċ*9N ~@ CK7 74.ݽy6&~=_n37j͹Kx  e NBWx; bSvrPG%7^fӍg;3iMK:m[y?kqEe~i7 |ibSi=rJG1`pdM>C J%ʡ'(kHv8q i17f|2)qG&6mQaSp\DI گxc\832)AP7%p/@)qklrJ.tE.H]a2!vpwm3&-<ÛiLNB 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443 0 obj<> endobj 444 0 obj<>stream HVr8+T lRkKNbW9FS$&a;eҖDI`g3VQ\Û7MYXYxsΊfoj)++ Pn&B\_| ߿[OŶ(]ZY e62p5z0 uO%0HIp7yF +E:l 'Wgz;- ֲm`%X7Yq oaYꇨLjtpL` Dg)EW.ޯhPJ (f5dUՠE'Dyau (cK1}>N5,[Pf-@>$?'E¥I3JkFFp̰.$q%ms, tWBj9YwpzU{8ZEAzMۦ,G) &S)ˢ.}D#Ǐ5 K+;:$uQTz;=˿VID6SzVbm =%MHcFl:gc,,%&EMSXY𬌌S'l_qID6*`fDE*/J91Xc) /]6$h\K5mM{_3׊`ЁKuK'TQx; bS/ƒ/YfAϴvft[?:1QVB\wQY{/V!<Ko)vG쌜]>Σm0دNڞ eohE-f ;4N 6voG+2$p@g8g)JK?fKd8ݭЉ7Ŏs1)yuUJe] l_6g Q&vwψcy~Ku3!&D_uh<[|xÖ05  endstream endobj 445 0 obj<> endobj 446 0 obj<> endobj 447 0 obj<>stream HVMsHW1Z曙TjmI*'و=%9$ @v~{[:0% o^yݳVQ\Û7MYXYxsΊfoj)++ Pn&B\_| ߿[OŶ(]ZY e62p5z0 uO%0HIp7yF m+E:n 'Wgz[ ְM`%X$VE yo Q$ҀTԭt:? {)̫Ю HtF=iYGcZ?OL#.ќ%[n$-,,N+yeyj5u`Q(ʸzhI՛tܤ|{)\~{ bU?De:USS%R?N1( p̸ܽp~Ŭ%FRFEwi^CVU{(Go&tc": ?t,p)ǩaZi) B~>).]M:1T"X34ct!c.ix`Iۢ~>UxQ7YK\\tP\:gݗe7%d=`YtYE1"{xF:ai~BGB?QgEӳkDdȺ?a%Mst4;evs[F"X?5bj 7 u|*."(ty0#:_LD`0Dt ذ qPηY.7v#B~N\'F՚sB.H<J.APG(,O)ܡKn$ 76vt<uHf_Cm Dy;eZѩ9%|m0خκ gE-.6h@Im3ONeܑIਁ pR-9 ~8L ˗(p[obFS&:Zc$].˺s /H޾"tلsnql:O?=,; zb&Ğɐ96#pum=@a" =Ҧ endstream endobj 448 0 obj<> endobj 449 0 obj<> endobj 450 0 obj<>stream HVMsHW1Z曙TjmI*'و=%9$ @v~{[:0% o^yݳVQ\Û7MYXYxsΊfoj)++ Pn&B\_| ߿[OŶ(]ZY e62p5z0 uO%0HIp7yF m+E:n 'Wgz[ ְM`%X$VE yo Q$ҀTԭt:? {)̫Ю HtF=iYGcZ?OL#.ќ%[n$-,,N+yeyj5u`Q(ʸzhI՛tܤ|{)\~{ bU?De:USS%R?N1( p̸ܽp~Ŭ%FRFEwi^CVU{(Go&tc": ?t,p)ǩaZi) B~>).]M:1T"X34ct!c.ix`Iۢ~>UxQ7YK\\tP\:gݗe7%d=`YtYE1"{xF:ai~BGB?QgEӳkDdȺ?a%Mst4;evs[F"X?5bj 7 u|*.kQlŒp4~2@N%`>2ƥRC:fyD؏G1sUk] ]PpBhw(&?|tp:j,:63nz38ظљ:"{}i7 |i[b{Dzhяb(`:kzJ(,'(kHv؟qhcxS<)qG&)KH(PZ!0$8._$nV1.vM 댍8tOJ,z{qJ&޾"mz(agMm'ıYgx<$ĺ뉙L{&Cڌ}?[|xmgÆ0޶ GE endstream endobj 451 0 obj<> endobj 452 0 obj<> endobj 453 0 obj<>stream HVr8+T lRkKUN(D:|~@J"eRD`{03JQ\Wm/0o>٧hfQ̮_R%V V@B׋9Lf% !综HIU1d?ؔp2 C BK`=s?Ƈ##% O%}WnnurNnO.n7,XB4A2bGz[(XVuYO=xcm$0nU$ud6x22Bz({:LH'CR=ԑjUjdhΈDw*,4NJYYmz=u`'w: 2.ZR6.n __| __2_WQjp2\0J["E;Š^qj0"`9YKэ p:,q7`fnЧ͕nlK^xnef"ʗ| hWm!Vc-wbPGGZƸq.f2)AP%pW3)q+=ۣp*SB7h pl"ۄS~olt!O|zX zib;2un]}1 9Tpk*m/9 endstream endobj 454 0 obj<> endobj 455 0 obj<> 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